Below you will find basic demographic and healthcare market data on Europe, plus specific information about the medical device and healthcare industries.

Overview of medical device industry: The medical device market in the EU accounts for one third of the global market, with around $122.5 billion (est. 2011) in yearly revenue. The industry consists of over 22,000 companies all over Europe that employ around half a million people.

Many European countries are leaders in medical device innovation and export their products all over the world. Germany, France, and Sweden are very competitive in other markets as well as in Europe.

Opportunities in the European market: Europe is a major hub for the global medical device industry. However, many European countries export their products to the other markets, and rely on imports to supply the domestic healthcare industry. Manufacturers producing in-demand technologies will find their products are well-received.

Industry challenges in Europe: Recent regulatory, economic, and political shifts in Europe could impact the medical device industry. The medical device manufacturers will transition to the new Medical Device Regulations and ISO 13485:2016, placing significant pressure on Notified Bodies. The relatively weak Euro continues to benefit European companies exporting to the US, but creates difficulties for some importers. Foreign manufacturers will continue to compete with large, multinational corporations operating and distributing in Europe. And, it is important to research the countries where your product will perform best, as healthcare industries vary significantly from one country to the next.

Within the UL family of companies we provide a broad portfolio of offerings to all the medical device industries. This includes certification, Notified Body and consultancy services. In order to protect and prevent any conflict of interest, perception of conflict of interest and protection of both our brand and our customers brands, UL is unable to provide consultancy services to Notified Body or MDSAP customers. UL has processes in place to identify and manage any potential conflicts of interest and maintain impartiality. Learn more here.